Important update on event submissions and edits01-May-2024
We are currently transitioning to a new 欧美AV events submission system and website. 鈥� New event submissions may take up to one week to be published while we complete the transition. 鈥� Editing existing events is temporarily unavailable. New edit links will be issued next week. Your patience is appreciated while we finalise these improvements to the 欧美AV events website. If you have any questions, please contact the Events Database Team eventsdatabase@rsc.org
Stability Testing in Pharmaceutical Development and Manufacturing
6 June 2019 09:00 - 7 June 2019 17:00, London, United Kingdom
Introduction
The course will cover: The impact of the lifecycle approach on product development:
The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
Product Quality Reviews, statistics, and the interpretation of stability data
Recent scientific developments with implications for stability, with a particular focus on cost reduction, shortening of development timelines, and improvements on existing interpretation systems.
ASAP - short term high stress testing to get accurate predictions of shelf life with a high degree of confidence 鈥� Freethink Technologies鈥� ASAPprime庐
Low level impurities and their impact on product stability
Manipulation of tablet internal pH to improve product stability
